ORBuys S-44300-00001995 OHA-RFA-5171 Final Form Price Agreement Attachment 3 AA Review Form.pdf

A. Manufacturer (or Trade Association) Submitting QEA:

Date Received by OHA:

PUBLIC HEALTH DIVISON

Center for Health Protection

[Section A for OHA use only]

Name:

B. Contractor Information:

Reviewer's Phone:

Firm Name:

Reviewer Name(s):

Reviewer’s Email:

Date Review Completed:

Directions for Contractor for Completion of Review Forms Please review this Alternatives Assessment (AA) submitted in support of a Waiver per Oregon Administrative Rule (OAR) 333-016-3040(2)(b). If approved, specified children's products containing High Priority Chemicals of Concern for Children's Health at or above de minimis may continue to be sold in Oregon. OAR 333-016-3060(2)(b) requires that AA's start with start with a Hazard Assessment (HA) of the proposed substitute chemical(s). The HA is to be followed by a Qualitative Exposure Assessment (QEA); technical feasibility assessment, and financial feasibility assessment1. The last three modules may be conducted in any order.

An HA conducted with GreenScreen methodology (OAR 333-016-3030(1)) is to be treated "as is" by Contractors and not evaluated. GreenScreen HAs are sent to Contractors to inform their evaluation of other modules. However, Contractors should evaluate HAs conducted with an alternative methodology (OAR 333-016-3030(4)). When this occurs, OHA will provide the approved alternative methodology and review forms to Contractors.

OARs for all four modules of an Alternative Assessment require that children's products for which a waiver is requested be identified per OAR 333-016-3010(3)(a) through (c) at the brand name, product model level (hereafter, BNPM or children's product). Each submitted module should refer to each BNPM for which the Waiver request is made. Contractors should cut-and-pasteΣ ƛƴǘƻ ŀƴ ŀǘǘŀŎƘƳŜƴǘΣ information identifying each BNPMΦ In the attachment, each BNPM should be give a unique identifier that may subsequently referred to in the Contractor's reviews. This attachment should be sent to OHA along with the completed Review Form(s) for an AA.

Review forms for the QEA, technical feasibility assessment, and financial feasibility assessment modules are on the following pages. The number of BNPMs included in each AA will vary. Aǘ ǘƘŜ ǘƻLJ ƻŦ ŜŀŎƘ FƻNJƳ is red-bordered spacŜΦ Contractor should list the unique identifiers for .bPM in the module. Manufacturers are allowed to aggregate responses for substantially similar BNPM per Item 6 in QEA Guidance. Therefore, /ontractors may evaluate such responses in ŀ ǎƛƴƎƭŜ wŜǾƛŜǿ CƻNJƳΦ However, contractors should note, in the space at the bottom of the QEA below, those aggregated BNPMs likely to have HPCCCH concentrations that vary more than 10% from concentrations of the same HPCCCHs in the group, thus not qualifying for aggregation. CƛƴŀƭƭȅΣ It///I ŘNJƻLJπŘƻǿƴ ƭƛǎǘǎ ŀNJŜ ŀǘ ǘƘŜ ǘƻLJ ƻŦ ŜŀŎƘ wŜǾƛŜǿ CƻNJƳΦ /ƻƴǘNJŀŎǘƻNJǎ ǎƘƻdzƭŘ ǎŜƭŜŎǘ It///Iǎ ŘƛǎŎdzǎǎŜd in the module. Review Forms may be reproduced, as needed, ensure a response to each BNPM and HPCCCH.

Questions? Please contact the Authority’s Toxic-Free Kids Program at toxicfreekids.program@dhsoha.state.or.us.

1A financial feasibility assessment is not required if an alternative chemical substitute(s) is not found to be technically feasible per OAR 333-016-3060(3).

AA Review Form - Ver 1.0

Kate Brown, Governor

Attachment 3 - Alternative Assessment (AA) Review Form (per OAR 333-016-3060)

SAMPLE

https://www.oregon.gov/oha/PH/HEALTHYENVIRONMENTS/HEALTHYNEIGHBORHOODS/TOXICSUBSTANCES/Documents/Guidance%20for%20Quantitative%20Exposure%20Assessment%20per%20OAR%20333-016-3050%20ver1.1.pdf https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276973 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276973 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276970 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276976 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276976 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276974

1. Does the description of the children's product provided adequately identify the product per OAR Adequate Inadequate 333-016-3010(3)? [Please see #3 in QEA Guidance.]

If adequate, what information is needed to change this conclusion?

2. STEP A - Do the exposure scenario(s) provided adequately describe how, if at all, the HPCCCH in the BNPM could reasonably be anticipated to enter a child’s body through a completed exposure pathway because of leachability and bioavailability from the BNPM? [Please see #4 in QEA Guidance.]

• If inadequate, briefly describe below identified deficiencies below.

QEA Review: List Brand name, Product Model (BNPM)

Summary Report for:

AA Review Form - Ver 1.0 3

Items 1-4 below described in QEA Guidance

3. STEP B - First Option - For each completed exposure pathway stated above, does the information submitted on the leachability and bioavailability of HPCCCH from a product adequately satisfy requirements of OAR 333-016-3050(2)(b)?

Reminder: per OAR 333-016-3050(6), to be approved a QEA for a BNPM must demonstrate that HPCCCCH concentrations measured in the appropriate media be less than or equal to the PQL of the HPCCCH established in OAR 333-016-2035(2) in effect for the biennial notice period for which the QEA is requested. [The Authority will

• If inadequate, briefly describe below identified deficiencies below.

Adequate Inadequate

4. STEP B - Second Option - Per OAR 333-016-3050(2)(c), does the information submitted adequately satisfy requirements of OAR 333-016-3050(2)(c)? Adequate Inadequate

Adequate Inadequatee

• Does the information provided adequately respond to the requirements of 333-016-3050(2)(a)?

provide correct version of OAR 333-016-2035(2) to Contractor.]

• If inadequate, briefly describe below identified deficiencies below.

Check this box if this QEA contains an aggregation of BNPMs not likely to meet criteria for aggregation per #6 of QEA Guidance? If so, please list Unique Identifiers for such BNPMs in the space below:

SAMPLE

Summary Report for:

AA Review Form - Ver 1.0 3

Technical Feasibility Review: List Brand name, Product Model (BNPM)

1. Per OAR 333-016-3060(6)(a), please assess the detailed analysis of the role of each HPCCCH in the product specified function, its application in the product (in a material, component, or manufacturing process) and whether the HPCCCH or function is non-essential, substitutable, essential, or a contaminant. Adequate Inadequate

If inadequate, what information is needed to change this conclusion?

2. Per OAR 333-016-3060(6)(b), for HPCCCH roles labeled as substitutable or non-essential, does the explanation with supporting evidence provided justify retaining the HPCCCH in the children’s product? Adequate Inadequat

If inadequate, what information is needed to change this conclusion?

3. Per OAR 333-016-3060(6)(c), please assess analysis of the role(s) played by each HPCCCH if labeled as non-essential, substitutable, or essential in the product for the reliability, quality, useful life and acceptability to consumers of the product. [See definitions of "non-essential, substitutable, or essential" in OAR 333-016-2010] Adequate Inadequate

If inadequate, what information is needed to change this conclusion?

4. Per OAR 333-016-3060(6)(d), please assess the explanation of why it not technically feasible for any identified alternate chemical substitutes to fulfill the roles specified in subsections (a) through (c) of this section.

Adequate Inadequate

If inadequate, what information is needed to change this conclusion?

SAMPLE

https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276959 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276976

Summary Report for:

AA Review Form - Ver 1.0

Financial Feasibility Review: List Brand name, Product Model (BNPM)

Per OAR 333-016-3060(7), To substantiate a claim that removal or substitution of a HPCCCH is not financially feasible, a manufacturer must provide to the Authority a price comparison of the cost to produce the children’s product with an alternative chemical to the current cost to produce the product. The comparison must include:

1. Per OAR 333-016-3060(7)(a), direct costs along the value-chain, such as product reformulation.

Adequate Inadequate If inadequate, what information is needed to change this conclusion?

2. Per OAR 333-016-3060(7)(b), retooling.

Adequate Inadequate If inadequate, what information is needed to change this conclusion?

3. Per OAR 333-016-3060(7)(c), research or other capital investment costs.

Adequate Inadequate If inadequate, what information is needed to change this conclusion?

4. Per OAR 333-016-3060(7)(d), an evaluation for adequate supply to meet demand.

Adequate Inadequate If inadequate, what information is needed to change this conclusion?

5. Per OAR 333-016-3060(7)(e), an evaluation of the potential reduction in price of the alternative chemical if the volume of the alternative chemical being purchased increases. Adequate Inadequate

If inadequate, what information is needed to change this conclusion?

4. Per OAR 333-016-3060(6)(d), please assess the explanation of why it not technically feasible for any identified alternate chemical substitutes to fulfill the roles specified in subsections (a) through (c) of this section.

Adequate Inadequate

If inadequate, what information is needed to change this conclusion?

SAMPLE